NCT01325597

Brief Summary

The purpose of this study is to assess the effects of functional electrical stimulation associated with inspiratory muscle training on functional capacity and quality of life in heart failure patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

6 years

First QC Date

March 14, 2011

Last Update Submit

March 10, 2015

Conditions

Heart Failure

Keywords

Heart failureElectric stimulationBreathing exercises

Outcome Measures

Primary Outcomes (1)

  • Functional capacity

    To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity.

    12 weeks

Secondary Outcomes (7)

  • Quality of life

    12 weeks

  • Peripheral muscle strength

    12 weeks

  • Pulmonary function

    12 weeks

  • Respiratory muscle strength

    12 weeks

  • Endothelial function

    12 weeks

  • +2 more secondary outcomes

Study Arms (4)

Combined training

EXPERIMENTAL

Training with functional electrical stimulation added by inspiratory muscle training.

Other: Electrical stimulationOther: Inspiratory muscle trainingOther: Control group

Electrical stimulation

EXPERIMENTAL

FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks

Other: Combined trainingOther: Inspiratory muscle trainingOther: Control group

Inspiratory muscle training

EXPERIMENTAL

IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure

Other: Combined trainingOther: Electrical stimulationOther: Control group

Control group

NO INTERVENTION

No intervention.

Interventions

Combined trainingOTHER

FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure.

Also known as: Electric stimulation, Electrical stimulation, Inspiratory muscle training, Breathing exercises
Electrical stimulationInspiratory muscle training
Electrical stimulationOTHER

FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks

Also known as: Electric stimulation, Eletric stimulation therapy
Combined trainingInspiratory muscle training
Inspiratory muscle trainingOTHER

IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure

Also known as: Respiratory muscle training, Breathing exercises
Combined trainingElectrical stimulation
Control groupOTHER

No intervention

Combined trainingElectrical stimulationInspiratory muscle training

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with stable heart failure and New York Heart Association (NYHA) class II-IV
  • Aged 30-70 years
  • Left ventricular ejection fraction less than 35% determined by echocardiography and optimized pharmacological treatment (unchanged 1 month prior to study)

You may not qualify if:

  • Patients with unstable heart failure
  • NYHA class I
  • Unstable angina pectoris and ventricular arrhythmia
  • Implanted cardiac pacemaker
  • Acute pulmonary diseases
  • Chronic renal failure or dialysis
  • Acute inflammatory diseases
  • Peripheral vascular disease
  • Neurologic disease
  • Musculoskeletal pathologies
  • Malignancies or being an active smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia

Porto Alegre, Rio Grande do Sul, 90.620-000, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Electric StimulationBreathing ExercisesControl Groups

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative TechniquesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesEpidemiologic Research DesignEpidemiologic MethodsResearch DesignMethods

Study Officials

  • Rodrigo DM Plentz, PhD

    Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo DM Plentz, PhD

CONTACT

+ 55 51 91794399roplentz@yahoo.com.br

Graciele Sbruzzi, MSc

CONTACT

+ 55 51 98899705graci_sbruzzi@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doutora

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 30, 2011

Study Start

March 1, 2010

Primary Completion

March 1, 2016

Study Completion

March 1, 2017

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

BR(1)